REG - Genedrive PLC - CYP2C19-ID Kit used to support expansion

GenedriveAnnouncement

13/05/2025 07:00

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RNS Number : 3261I  Genedrive PLC  13 May 2025

genedrive plc

("genedrive" or the "Company")

 

Genedrive® CYP2C19-ID Kit to be used to support expansion of use to include
Acute Coronary Syndrome

 

genedrive plc (AIM: GDR), the point of care pharmacogenetic testing company,
announces the use of the Genedrive® CYP2C19-ID Kit in a trial led by
Manchester University Foundation Trust ("MFT") in collaboration with the
Genotype Guided Primary Coronary Intervention ("GUIDE PCI") programme and the
British Heart Foundation ("BHF") Centre of Excellence, which aims to assess
the value and feasibility of rapid point of care CYP2C19 testing in
cardiovascular disease to improve patient outcomes. The sales value of the
order is circa. £120K.

 

CYP2C19 genotyping is already recommended by the National Institute for Health
& Care Excellence ("NICE") prior to treatment with the antiplatelet
Clopidogrel in Ischaemic Stroke ("IS") and Transient Ischaemic Attack ("TIA"),
with the Genedrive® CYP2C19-ID kit recommended as the first line point of
care test to be used in the UK NHS.

 

There are more than 7.6 million people living with a heart or circulatory
disease in the UK, and over 100,000 hospital admissions each year due to heart
attacks, with these patients often requiring lifelong antiplatelet therapy.
The American Heart Association ("AHA") recently released a scientific
statement recommending CYP2C19 genetic testing in cardiovascular indications
such as Acute Coronary Syndrome ("ACS"), with an emphasis on results being
available rapidly(1). The GUIDE PCI programme at MFT aims to embed the
Genedrive® CYP2C19-ID Kit into routine PCI clinical practice. Over a 12-month
period, clinicians will use the Genedrive® CYP2C19-ID Kit for patients
undergoing PCI, rapidly identifying which antiplatelet therapy they should
receive. The programme will establish the feasibility and value of this
intervention, supporting roll out at other centres.

 

Dr Gino Miele, CEO of genedrive plc, said: "We are delighted that our CYP2C19
rapid genetic test is being assessed for use in ACS and PCI procedures in
addition to current clinical recommendations by NICE for use prior to
prescription of Clopidogrel in IS and TIA. With clinical recommendations for
CYP2C19 genetic testing for IS, TIA and ACS, and with rapid genetic testing
within 24 hours being recommended if clopidogrel is being considered, our
CYP2C19 test is well positioned to enable this intervention and care pathway
change, significantly improving patient outcomes whilst at the same time
freeing healthcare resources and finances."

 

Dr Jaydeep Sarma, Consultant Interventional Cardiologist in Greater
Manchester, said: "The Greater Manchester Regional Primary PCI service
operates 24 hours a day, 7 days a week, 365 days a year. Thousands of patients
are seen rapidly for life saving interventions from across the region each
year and it's essential that their treatments are optimised as quicky as
possible. Integration of this rapid test into routine practice means we can
get patients on the right treatment the first time, improving outcomes for our
patients and the service as a whole."

 

Professor Maciej Tomaszewski, Deputy Director at the British Heart Foundation
Manchester Centre of Research Excellence, said: "This is fantastic example of
pharmacogenomics research in action, which has the potential to change
clinical practice in cardiology clinics, wards and hospitals. The BHF
Manchester CRE supports cardiovascular pharmacogenomics research and the
follow up implementation programmes across the spectrum of cardiovascular
diseases."

 

Bill Newman, Professor of Translational Genomic Medicine at University of
Manchester, Consultant in Genomic Medicine at MFT, and a researcher with the
National Institute for Health and Care Research (NIHR) Manchester BRC, said:
"We're already seeing the impact of rapid genetic testing for patients who
have had stroke or TIAs, with our colleagues in centres around the country
telling us they need results quickly to inform their practice and avoid delays
to discharge. The evidence bases for genotype guided antiplatelet therapy in
cardiovascular disease is arguably even stronger than for patients who have
stroke or TIA. The Guide PCI programme is a logical extension of our
pharmacogenomics programme and reflects the regions commitment to personalised
medicine."

 

For further details please contact:

 

 genedrive plc                                     +44 (0)161 989 0245
 Gino Miele: CEO / Russ Shaw: CFO

 Peel Hunt LLP (Nominated Adviser and Broker)      +44 (0)20 7418 8900
 James Steel

 Walbrook PR Ltd (Media & Investor Relations)      +44 (0)20 7933 8780 or genedrive@walbrookpr.com
                                                   (mailto:genedrive@walbrookpr.com)
 Anna Dunphy                                       +44 (0)7876 741 001

 

 

About genedrive plc (http://www.genedriveplc.com)

genedrive plc is a pharmacogenetic testing company developing and
commercialising a low cost, rapid, versatile and simple to use point of need
pharmacogenetic platform for the diagnosis of genetic variants. This helps
clinicians to quickly access key genetic information that will aid them make
the right choices over the right medicine or dosage to use for an effective
treatment, particularly important in time-critical emergency care healthcare
paradigms. Based in the UK, the Company is at the forefront of Point of Care
pharmacogenetic testing in emergency healthcare. Pharmacogenetics informs on
how your individual genetics impact a medicines ability to work for you.
Therefore, by using pharmacogenetics, medicine choices can be personalised,
made safer and more effective. The Company has launched its two flagship
products, the Genedrive® MT-RNR1 ID Kit and the Genedrive® CYP2C19 ID Kit,
both developed and validated in collaboration with NHS partners and deployed
on its point of care thermocycler platform. Both tests are single-use
disposable cartridges which are ambient temperature stable, circumventing the
requirement for cold chain logistics. The Directors believe the Genedrive®
MT-RNR1 ID Kit is a worlds-first and allows clinicians to make a decision on
antibiotic use in neonatal intensive care units within 26 minutes, ensuring
vital care is delivered, avoiding adverse effects potentially otherwise
encountered and with no negative impact on the patient care pathway. Its
CYP2C19 ID Kit which has no comparably positioned competitor currently allows
clinicians to make a decision on the use of Clopidogrel in stroke patients in
70 minutes, ensuring that patients who are unlikely to benefit from or suffer
adverse effects from Clopidogrel receive an alternative antiplatelet
therapeutic in a timely manner, ultimately improving outcomes. Both tests have
undergone review by the National Institute for Health and Care Clinical
Excellence ("NICE") and have been recommended for use in the UK NHS.  The
Company has a clear commercial strategy focused on accelerating growth through
maximising in-market sales, geographic and portfolio expansion and strategic
M&A, and operates out of its facilities in Manchester.

 

(1) https://www.ahajournals.org/doi/epdf/10.1161/CIR.0000000000001257
(https://www.ahajournals.org/doi/epdf/10.1161/CIR.0000000000001257)

 

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